Prospective comparison of Coronary Computed-Tomography-Angiography (CCTA) with Near-Infrared Spectroscopy-Intravascular Ultrasound (NIRS-IVUS) in patients with angina.

Prospective comparison of Coronary Computed-Tomography-Angiography (CCTA) with Near-Infrared Spectroscopy-Intravascular Ultrasound (NIRS-IVUS) in patients with angina. - CCTA vs. NIRS-IVUS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038652

Enrollment

100

Registered

2025-12-05

Start date

2026-05-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25 I24 I21

Interventions

Group 1: The conduct of the present study comprises two main cohorts: patients with stable angina pectoris (CCS) and patients with unstable angina pectoris or non–ST-segment elevation myocardial infar

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age > 18 years - Stable angina pectoris, CCS class I–III, or - Acute coronary syndrome: NSTE-ACS, hemodynamically stable - Willingness to participate and ability to understand, read, and sign the informed consent form prior to the planned procedure - CCTA performed based on an appropriate clinical indication - Indication for invasive coronary evaluation and suitability for coronary angiography and/or percutaneous coronary intervention

Exclusion criteria

Exclusion criteria: - Cardiogenic shock and/or hemodynamic instability (Killip class III–IV) - Severely impaired renal function: GFR < 30 ml/min/1.73 m² - Atrial fibrillation at the time of imaging or invasive evaluation - Pregnancy, intention to become pregnant during the study period, or breastfeeding - Documented intolerance to contrast agents, beta-blockers, or nitroglycerin - Significant documented contraindication to intravenous nitroglycerin administration, e.g., severe aortic valve stenosis - STEMI within 24 hours prior to the procedure - Individuals under judicial or governmental custody in an institution

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the evaluation of the accuracy (sensitivity and specificity) of CCTA for the detection of lipid-rich plaques at the segment level (plaque burden = 40%, necrotic core volume = 1 mm³, necrotic core = 75 HU) and lipid-core plaques (LCP, = 30 HU), as identified by NIRS-IVUS as the reference standard in patients with chronic and acute coronary syndromes. In our patient cohort, the following parameters will be assessed: plaque burden within the minimal lumen area (plaque volume within the entire vessel cross-sectional area on a given slice, PB) = 40%, and necrotic core volume (cut-off = 1 mm³). Plaque composition will be categorized according to Hounsfield units (HU) into the following components: calcified plaque (> 350 HU), fibrous plaque (131-350 HU), fibro-fatty plaque (76-130 HU), and necrotic core (= 75 HU).	—

Measure

Time frame

The primary endpoint of this study is the evaluation of the accuracy (sensitivity and specificity) of CCTA for the detection of lipid-rich plaques at the segment level (plaque burden = 40%, necrotic core volume = 1 mm³, necrotic core = 75 HU) and lipid-core plaques (LCP, = 30 HU), as identified by NIRS-IVUS as the reference standard in patients with chronic and acute coronary syndromes. In our patient cohort, the following parameters will be assessed: plaque burden within the minimal lumen area (plaque volume within the entire vessel cross-sectional area on a given slice, PB) = 40%, and necrotic core volume (cut-off = 1 mm³). Plaque composition will be categorized according to Hounsfield units (HU) into the following components: calcified plaque (> 350 HU), fibrous plaque (131-350 HU), fibro-fatty plaque (76-130 HU), and necrotic core (= 75 HU).

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Secondary

Measure	Time frame
- Plaque dimensions, including total atheroma volume (mm³) and percent atheroma volume (%), vessel area (mm²) and vessel volume (mm³), lumen area (mm²) and lumen volume (mm³), as well as lesion length (mm). - The presence and extent of a lipid-core plaque (defined as lipid-core diameter > 200 µm, arc > 60 degrees, and cap thickness < 450 µm) will likewise be assessed and quantified by CT. In addition, lipid components, the Lipid Core Burden Index (LCBI), based on the distribution of lipid-rich plaque, and the 4-mm segment with the maximal LCBI (maxLCBI4mm) will be estimated and compared between the two imaging modalities. A maxLCBI4mm = 400 can serve as a specific marker for the identification of plaques underlying acute coronary syndromes. - The assessment of the perivascular fat attenuation index (FAI) represents a promising area of research. Studies have demonstrated that FAI improves cardiac risk prediction and stratification compared with established methods by providing a quantitative measure of coronary inflammation, thereby offering additional pathophysiological insights. - Comparison of quantitative and qualitative plaque parameters obtained by spectral CCTA with results from the invasive reference standard (NIRS-IVUS), including plaque composition, lipid content, plaque volume, and plaque vascularization. The objective of this endpoint is to evaluate diagnostic concordance (e.g., via correlation analyses and ROC analyses) between non-invasive and invasive imaging in order to assess the potential of spectral CT data as surrogate markers for vulnerable plaques. - Follow-up at 3, 6, 12, and 24 months regarding major adverse cardiovascular events (MACE), particularly in patients with high-risk lesions.	—

Measure

Time frame

- Plaque dimensions, including total atheroma volume (mm³) and percent atheroma volume (%), vessel area (mm²) and vessel volume (mm³), lumen area (mm²) and lumen volume (mm³), as well as lesion length (mm). - The presence and extent of a lipid-core plaque (defined as lipid-core diameter > 200 µm, arc > 60 degrees, and cap thickness < 450 µm) will likewise be assessed and quantified by CT. In addition, lipid components, the Lipid Core Burden Index (LCBI), based on the distribution of lipid-rich plaque, and the 4-mm segment with the maximal LCBI (maxLCBI4mm) will be estimated and compared between the two imaging modalities. A maxLCBI4mm = 400 can serve as a specific marker for the identification of plaques underlying acute coronary syndromes. - The assessment of the perivascular fat attenuation index (FAI) represents a promising area of research. Studies have demonstrated that FAI improves cardiac risk prediction and stratification compared with established methods by providing a quantitative measure of coronary inflammation, thereby offering additional pathophysiological insights. - Comparison of quantitative and qualitative plaque parameters obtained by spectral CCTA with results from the invasive reference standard (NIRS-IVUS), including plaque composition, lipid content, plaque volume, and plaque vascularization. The objective of this endpoint is to evaluate diagnostic concordance (e.g., via correlation analyses and ROC analyses) between non-invasive and invasive imaging in order to assess the potential of spectral CT data as surrogate markers for vulnerable plaques. - Follow-up at 3, 6, 12, and 24 months regarding major adverse cardiovascular events (MACE), particularly in patients with high-risk lesions.

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Countries

Germany

Contacts

Public ContactMarios Antoniadis

Klinik und Poliklinik für Kardiologie am Universitätsklinikum Leipzig

marios.antoniadis@medizin.uni-leipzig.de+49 341 9711729

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026